Quality Operations Engineer

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. As we continue to develop healthcare products and expand our business globally, we are consistently looking for new talents.

Right now, we are seeking highly qualified candidates to fill the position: Quality Operations Engineer

Role Description:The role of QA Release Engineer is situated within the QA Operations team which is responsible for Quality Assurance of the operational activities related to the production of vaccines at the Pfizer site in Puurs.

"As QA Release Engineer you are the primary contact for the Production department in case of quality deviations."

In addition, you are accountable for releasing vaccines to the market in accordance with cGMP and Company and Legal requirements. In addition, you will perform and document all necessary investigations to support assessment of the sterile product being acceptable and make proposals for continuous improvement of products and processes.

You report to the QA Lead in a vaccines oriented organization.

Main Responsibilities:

You will assure that products manufactured and packaged in Puurs meet cGMP and Company and Legal requirements.

You will investigate batches not meeting specifications and prepare recommendations to the QA Manager / QA Lead.

You coordinate cross functional investigations in case of complex root causes and work closely with Production and supporting departments.

You evaluate root cause analyses, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.

You evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager / QA lead.

You operate and maintain the Quality Assurance systems.

You approve master documents and SOP's.

You review batch related manufacturing documentation for conformity.

You prepare necessary release documentation for your area (incl. activities related to OMCL release of vaccines).

You prepare Annual Product Reviews and Quality Performance Review.

You support continuous improvement of products and processes through:

quality investigations (deviations)

trending of deviations

participation in operations and system teams

You contribute to timely supply of products.

You can be requested to participate in assignments as defined by the QA Manager / QA Lead.

You release batches that meet Company and Legal requirements and in alignment with a Global Quality Network.

Qualifications:

University degree in a scientific discipline, preferably in Pharmacy.

Experience in Production (preferably at least 3 years), quality investigations and release of biological products or vaccines is an advantage.

You have very good analytical skills.

You have excellent communication skills both oral and written (Dutch/English).

You have excellent documentation skills (technical report writing in Dutch/English).

You have good project management skills (cost, time, scope); handling conflicting priorities.

You are diplomatic but surely convincing within an assertive attitude.